Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco; Availability, 25271-25272 [2010-10934]

Download as PDF Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices sustainability of programs and services that help newly-arrived refugees secure employment, overcome language and cultural barriers, become economically self-sufficient, and integrate into their new communities. Through this provision of technical assistance, ECDC will ensure a more effective service component by focusing on reducing social service gaps, increasing refugee access to mainstream resources and services, and helping CBOs build capacity and sustainability. Contact for Further Information: Kenneth Tota, Deputy Director, Office of Refugee Resettlement, 901 D Street, SW., Washington, DC 20047. Telephone: 202–401–4858; e-mail: ktota@acf.hhs.gov. Dated: April 28, 2010. Eskinder Negash, Director, Office of Refugee Resettlement. [FR Doc. 2010–10809 Filed 5–6–10; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Office of Refugee Resettlement; Urgent Single Source Grant to Survivors of Torture International (SOTI) jlentini on DSKJ8SOYB1PROD with NOTICES AGENCY: Office of Refugee Resettlement, ACF, HHS. ACTION: Notice to Award an Urgent Single Source Grant to Survivors of Torture International (SOTI). CFDA Number: 93.604. Legislative Authority: ‘‘Torture Victims Relief Act (TVRA) of 1998,’’ Public Law 105–320 (22 U.S.C. 2152 note), reauthorized by Public Law 109– 165 in January 2006. Section 5(a) provides for ‘‘Assistance for Treatment of Torture Victims.—The Secretary of Health and Human Services may provide grants to programs in the United States to cover the cost of the following services: (1) Services for the rehabilitation of victims of torture, including treatment of the physical and psychological effects of torture. (2) Social and legal services for victims of torture. (3) Research and training for health care providers outside of treatment centers, or programs for the purpose of enabling such providers to provide the services described in paragraph (1).’’ Amount of Award: $271,000. Project Period: March 1, 2010 through February 28, 2011. Summary: Notice is hereby given that an urgent single-source award will be VerDate Mar<15>2010 19:19 May 06, 2010 Jkt 220001 made to Survivors of Torture International (SOTI), San Diego, CA, to provide comprehensive rehabilitative services to incoming Iraqi and other survivors of torture, who are in need of specialized services, to regain their health and independence and rebuild productive lives. In addition to providing direct services, SOTI will train area providers to effectively serve this population and leverage resources within the community. SOTI will also focus on building and sustaining collaboration among other providers to serve this population. In Fiscal Year (FY) 2010, due to an increase in the funding appropriation under the TVRA, an additional amount of $271,000 is available for direct services through the Office of Refugee Resettlement (ORR) Services for Survivors of Torture Program. In FY 2009, a total of 3,667 Iraqi refugees and holders of Special Immigrant Visas were resettled in the San Diego metropolitan area. Some of these individuals have suffered torture prior to arrival in the United States and are in need of specialized services. San Diego, CA, is the area of the country most heavily impacted in terms of Iraqi refugee arrivals. SOTI has a long history of serving torture survivors in San Diego county, has developed a large network of pro bono providers, is well known in the community, and possesses the clinical and programmatic expertise to serve the survivors. FOR FURTHER INFORMATION CONTACT: Ronald Munia, Director, Division of Community Resettlement, Office of Refugee Resettlement, 901 D Street, SW., Washington, DC 20047. Telephone: 202–401–4559. E-mail: Ronald.Munia@acf.hhs.gov. Dated: April 28, 2010. Eskinder Negash, Director, Office of Refugee Resettlement. [FR Doc. 2010–10810 Filed 5–6–10; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0189] Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00087 Fmt 4703 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco.’’ This guidance document discusses FDA’s intended enforcement policies with respect to two provisions of the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. One provision restricts the use of a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product. The second provision requires that labeling or print advertisements appear in a black-andwhite text only format, except in certain ‘‘adult only’’ locations or in publications that do not have significant readership by children and adolescents under the age of 18. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency’s good guidance practices (GGPs). DATES: Submit electronic or written comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco’’ to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850– 3229. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments to https:// www.regulations.gov. Submit written comments concerning this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1–877–287–1373, annette.marthaler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Sfmt 4703 25271 E:\FR\FM\07MYN1.SGM 07MYN1 jlentini on DSKJ8SOYB1PROD with NOTICES 25272 Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices I. Background In the Federal Register of March 19, 2010 (75 FR 13225), FDA published final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. This guidance document discusses FDA’s intended enforcement policies with respect to two provisions of the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. One provision, § 1140.16(a) (21 CFR 1140.16(a)), specifies that manufacturers may not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product unless the trade or brand name was on both the tobacco product and a nontobacco product sold in the United States on January 1, 1995. FDA is aware of concerns regarding this provision and is considering what changes, if any, would be appropriate to address those concerns.1 While FDA has this issue under consideration, it intends to exercise its enforcement discretion concerning § 1140.16(a) (21 CFR 1140.16(a)) not to commence enforcement actions under this provision for the duration of its consideration where: (1) The trade or brand name of the cigarettes or smokeless tobacco product was registered, or the product was marketed, in the United States on or before June 22, 2009; or (2) The first marketing or registration in the United States of the tobacco product occurs before the first marketing or registration in the United States of the nontobacco product bearing the same name; provided, however, that the tobacco and nontobacco product are not owned, manufactured, or distributed by the same, related, or affiliated entities (including as a licensee). The second provision is § 1140.32(a) (21 CFR 1140.32(a)). Under this section of the final rule, manufacturers, distributors, and retailers must use only black text on a white background for labeling or advertising (with certain exceptions). The United States District Court for the Western District of Kentucky recently issued an order permanently enjoining FDA from enforcing § 1140.32(a) (formerly 21 CFR 897.32(a) of the 1996 final rule that published in the Federal Register of August 28, 1996 (61 FR 44396)) 1 Under section 102(a)(3)-(4) of the Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387a-1(a)(3)-(4)), FDA may amend the final rule after issuing a proposed rule for notice and comment. VerDate Mar<15>2010 19:19 May 06, 2010 Jkt 220001 (Commonwealth Brands, Inc. v. United States, No. 1:09-CV-117-M (W.D. Ky. Jan. 4, 2010)). As required by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the effective date for § 1140.32(a) is June 22, 2010. At this time, however, in light of the court’s order in Commonwealth Brands, FDA intends to exercise its enforcement discretion concerning § 1140.32(a) not to commence enforcement actions under this provision during the pendency of the litigation irrespective of whether the entity is a party to the pending lawsuit or located in the Western District of Kentucky. FDA intends that the exercise of enforcement discretion expressed in this guidance document for §§ 1140.16(a) and 1140.32(a) begin upon the effective date of the final rule (June 22, 2010). In accordance with FDA’s GGP regulation (§ 10.115 (21 CFR 10.115)), you may comment on this guidance at any time. The agency will consider your comments and determine whether to revise the guidance at a later date. II. Significance of Guidance FDA is issuing this guidance document as a level 1 guidance consistent with FDA’s GGP regulation (§ 10.115). This guidance document is being implemented immediately without prior public comment under § 10.115(g)(2) because the agency has determined that prior public participation is not feasible or appropriate. This document provides guidance on regulations that are required by statute (section 102 of the Tobacco Control Act); moreover, the statute directs that the regulations take effect on June 22, 2010 (section 102(a)(2)(F) of the Tobacco Control Act). It is important that FDA explain its enforcement policy for these two provisions before that date. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access An electronic version of the guidance document is available on the Internet at PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 https://www.regulations.gov and https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm. Dated: May 4, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–10934 Filed 5–5–10; 11:15 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Advisory Committee for Women’s Services; Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given of a meeting of the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Advisory Committee for Women’s Services (ACWS) on May 26–27 at SAMHSA. The meeting is open to the public. It will include reports from the SAMHSA Administrator and the ACWS Chair, Updates from ACWS members, and a discussion of SAMHSA’s strategic initiatives. Attendance by the public will be limited to space available. Public comments are welcome. The meeting can also be accessed via Webstream. To obtain the access information, to register, to submit written or brief oral comments, or to request special accommodations for persons with disabilities, please register at the SAMHSA Committee’s Web site at https://nac.samhsa.gov/Registration/ meetingsRegistration.aspx or communicate with the Designated Federal Officer for the ACWS, Ms. Nevine Gahed (see contact information below). Substantive meeting information and a roster of Committee members may be obtained either by accessing the SAMHSA Committee’s Web site at https://nac.samhsa.gov/ WomenServices/index.aspx, or by contacting Ms. Gahed. The transcript for the meeting will be available on the SAMHSA Committee’s Web site within three weeks after the meeting. Committee Name: SAMHSA’s Advisory Committee for Women’s Services. Date/Time/Type: Wednesday, May 26, 2010 from 9 a.m. to 5 p.m. EST: OPEN. Thursday, May 27, 2010 from 9 a.m. to 12 noon EST: OPEN. Place: 1 Choke Cherry Road, Seneca Conference Room, Rockville, Maryland 20857. Contact: Nevine Gahed, Designated Federal Officer, SAMHSA Advisory Committee for Women’s Services, 1 Choke Cherry Road, E:\FR\FM\07MYN1.SGM 07MYN1

Agencies

[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25271-25272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10934]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0189]

Guidance for Industry and Food and Drug Administration Staff;
Enforcement Policy Concerning Certain Regulations Restricting the Sale
and Distribution of Cigarettes and Smokeless Tobacco; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Enforcement Policy Concerning
Certain Regulations Restricting the Sale and Distribution of Cigarettes
and Smokeless Tobacco.'' This guidance document discusses FDA's
intended enforcement policies with respect to two provisions of the
final regulations restricting the sale and distribution of cigarettes
and smokeless tobacco to protect children and adolescents. One
provision restricts the use of a trade or brand name of a nontobacco
product as the trade or brand name for a cigarette or smokeless tobacco
product. The second provision requires that labeling or print
advertisements appear in a black-and-white text only format, except in
certain ``adult only'' locations or in publications that do not have
significant readership by children and adolescents under the age of 18.
This guidance document will be implemented immediately, but it remains
subject to comment in accordance with the agency's good guidance
practices (GGPs).

DATES: Submit electronic or written comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Enforcement Policy Concerning Certain Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco'' to the Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send
one self-addressed adhesive label to assist that office in processing
your request or include a fax number to which the guidance document may
be sent. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments to https://www.regulations.gov. Submit
written comments concerning this guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373, annette.marthaler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

[[Page 25272]]

I. Background

In the Federal Register of March 19, 2010 (75 FR 13225), FDA
published final regulations restricting the sale and distribution of
cigarettes and smokeless tobacco to protect children and adolescents.
This guidance document discusses FDA's intended enforcement policies
with respect to two provisions of the final regulations restricting the
sale and distribution of cigarettes and smokeless tobacco to protect
children and adolescents.
One provision, Sec. 1140.16(a) (21 CFR 1140.16(a)), specifies that
manufacturers may not use a trade or brand name of a nontobacco product
as the trade or brand name for a cigarette or smokeless tobacco product
unless the trade or brand name was on both the tobacco product and a
nontobacco product sold in the United States on January 1, 1995. FDA is
aware of concerns regarding this provision and is considering what
changes, if any, would be appropriate to address those concerns.\1\
While FDA has this issue under consideration, it intends to exercise
its enforcement discretion concerning Sec. 1140.16(a) (21 CFR
1140.16(a)) not to commence enforcement actions under this provision
for the duration of its consideration where:
---------------------------------------------------------------------------

\1\ Under section 102(a)(3)-(4) of the Family Smoking Prevention
and Tobacco Control Act (21 U.S.C. 387a-1(a)(3)-(4)), FDA may amend
the final rule after issuing a proposed rule for notice and comment.
---------------------------------------------------------------------------

(1) The trade or brand name of the cigarettes or smokeless tobacco
product was registered, or the product was marketed, in the United
States on or before June 22, 2009; or
(2) The first marketing or registration in the United States of the
tobacco product occurs before the first marketing or registration in
the United States of the nontobacco product bearing the same name;
provided, however, that the tobacco and nontobacco product are not
owned, manufactured, or distributed by the same, related, or affiliated
entities (including as a licensee).
The second provision is Sec. 1140.32(a) (21 CFR 1140.32(a)). Under
this section of the final rule, manufacturers, distributors, and
retailers must use only black text on a white background for labeling
or advertising (with certain exceptions). The United States District
Court for the Western District of Kentucky recently issued an order
permanently enjoining FDA from enforcing Sec. 1140.32(a) (formerly 21
CFR 897.32(a) of the 1996 final rule that published in the Federal
Register of August 28, 1996 (61 FR 44396)) (Commonwealth Brands, Inc.
v. United States, No. 1:09-CV-117-M (W.D. Ky. Jan. 4, 2010)). As
required by section 102 of the Family Smoking Prevention and Tobacco
Control Act (Tobacco Control Act), the effective date for Sec.
1140.32(a) is June 22, 2010. At this time, however, in light of the
court's order in Commonwealth Brands, FDA intends to exercise its
enforcement discretion concerning Sec. 1140.32(a) not to commence
enforcement actions under this provision during the pendency of the
litigation irrespective of whether the entity is a party to the pending
lawsuit or located in the Western District of Kentucky.
FDA intends that the exercise of enforcement discretion expressed
in this guidance document for Sec. Sec. 1140.16(a) and 1140.32(a)
begin upon the effective date of the final rule (June 22, 2010). In
accordance with FDA's GGP regulation (Sec. 10.115 (21 CFR 10.115)),
you may comment on this guidance at any time. The agency will consider
your comments and determine whether to revise the guidance at a later
date.

II. Significance of Guidance

FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's GGP regulation (Sec. 10.115). This guidance
document is being implemented immediately without prior public comment
under Sec. 10.115(g)(2) because the agency has determined that prior
public participation is not feasible or appropriate. This document
provides guidance on regulations that are required by statute (section
102 of the Tobacco Control Act); moreover, the statute directs that the
regulations take effect on June 22, 2010 (section 102(a)(2)(F) of the
Tobacco Control Act). It is important that FDA explain its enforcement
policy for these two provisions before that date.

III. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

An electronic version of the guidance document is available on the
Internet at https://www.regulations.gov and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

Dated: May 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10934 Filed 5-5-10; 11:15 am]
BILLING CODE 4160-01-S

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